Super and Nonresponders to Catheter Ablation for Atrial Fibrillation: A Quality-of-Life Assessment Using Patient Reported Outcomes.

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Left ventricular hypertrophy and antiarrhythmic drugs in atrial fibrillation: impact on mortality.

BACKGROUND: Despite sparse clinical data, current atrial fibrillation (AF) guidelines favor amiodarone as a drug of choice for patients with left ventricular hypertrophy (LVH). OBJECTIVE: This study tested the hypothesis that patients with persistent AF and LVH on nonamiodarone antiarrhythmics have higher mortality compared to patients on amiodarone. METHODS: In an observational cohort analysis of patients who underwent cardioversion for AF, patients with LVH, defined as left ventricular wall thickness ≥1.4 cm, by echocardiogram prior to their first cardioversion, were included; clinical data, including antiarrhythmic drugs and ejection fraction (LVEF), were collected. Mortality, determined via the Social Security Death Index, was analyzed using Kaplan-Meier and Cox proportional hazards models to determine whether antiarrhythmic drugs were associated with higher mortality. RESULTS: In 3,926 patients, echocardiographic wall thickness was available in 1,399 (age 66.8 ± 11.8 years, 67% male, LVEF 46 ± 15%, septum 1.3 ± 0.4, posterior wall 1.2 ± 0.2 cm), and 537 (38%) had LVH ≥1.4 cm. Among 537 patients with LVH, mean age was 67.5 ± 11.7 years, 76.4% were males, and mean LVEF was 48.3 ± 13.3%. Amiodarone was associated with lower survival (log rank P = 0.001), including after adjusting for age, LVEF, and coronary artery disease (P = 0.023). In propensity-score matched cohorts with LVH treated with no drugs, nonamiodarone antiarrhythmic drugs (non-AADs), or amiodarone (N = 65 each group), there was early lower survival in patients on amiodarone (P = 0.05). CONCLUSIONS: Patients with persistent AF and LVH on non-AADs do not have higher mortality compared to patients on amiodarone. Importantly, these findings do not support amiodarone as a superior choice in patients with LVH.

Implantable cardioverter-defibrillator FDA safety advisories: Impact on patient mortality and morbidity.

BACKGROUND: A significant proportion of implantable cardioverter-defibrillators (ICDs) have been subject to Food and Drug Administration (FDA) advisories. The impact of device advisories on mortality or patient care is poorly understood. Although estimated risks of ICD generators under advisory are low, dependency on ICD therapies to prevent sudden death justifies the assessment of long-term mortality. OBJECTIVE: To test the association of FDA advisory status with long-term mortality. METHODS: The study was a retrospective, single-center review of clinical outcomes, including device malfunctions, in patients from implantation to either explant or death. Patients with ICDs first implanted at Cleveland Clinic between August 1996 and May 2004 who became subject to FDA advisories on ICD generators were identified. Mortality was determined by using the Social Security Death Index. RESULTS: In 1644 consecutive patients receiving first ICD implants, 704 (43%) became subject to an FDA advisory, of which 172 (10.5%) were class I and 532 (32.3%) were class II. ICDs were explanted before advisory notifications in 14.0% of class I and 10.1% of class II advisories. Among ICDs under advisory, 28 (4.0%) advisory-related and 15 non-advisory- related malfunctions were documented. Over a median follow-up of 70 months, 814 patients died. Kaplan-Meier 5-year survival rate was 65.6% overall, and 64.2, 61.1, and 69.3% in patients with no, class I, and class II advisories, respectively (P = .17). CONCLUSIONS: ICD advisories impacted 43% of the patients. Advisory-related malfunctions affected 4% within the combined advisory group. Based on a conservative management strategy, ICDs under advisory were not associated with increased mortality over a background of significant disease-related mortality.

Aggregate national experience with the wearable cardioverter-defibrillator: event rates, compliance, and survival.

OBJECTIVES: The purpose of this study was to determine patient compliance and effectiveness of antiarrhythmic treatment by the wearable cardioverter-defibrillator (WCD). BACKGROUND: Effectiveness of the WCD for prevention of sudden death is dependent on event type, patient compliance, and appropriate management of ventricular tachycardia/ventricular fibrillation (VT/VF). METHODS: Compliance and events were recorded in a nationwide registry of post-market release WCDs. Survival, using the Social Security Death Index, was compared with survival in implantable cardioverter-defibrillator (ICD) patients. RESULTS: Of 3,569 patients wearing the WCD (age 59.3+/-14.7 years, duration 52.6+/-69.9 days), daily use was 19.9+/-4.7 h (>90% of the day) in 52% of patients. More days of use correlated with higher daily use (p<0.001). Eighty sustained VT/VF events occurred in 59 patients (1.7%). First-shock success was 76 of 76 (100%) for unconscious VT/VF and 79 of 80 (99%) for all VT/VF. Eight patients died after successful conversion of unconscious VT/VF (89.5% survival of VT/VF events). Asystole occurred in 23 (17 died), pulseless electrical activity in 2, and respiratory arrest in 1 (3 died), representing 24.5% of sudden cardiac arrests. During WCD use, 3,541 of 3,569 patients (99.2%) survived overall. Survival occurred in 72 of 80 (90%) VT/VF events and 78 of 106 (73.6%) for all events. Long-term mortality was not significantly different from first ICD implant patients but highest among patients with traditional ICD indications. CONCLUSIONS: Compliance was satisfactory with 90% wear time in >50% of patients and low sudden death mortality during use. Survival was comparable to that of ICD patients. However, asystole was an important cause of mortality in sudden cardiac arrest events.